Katy Koski

Katy Koski

K&L Gates LLP

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OIG Reveals Pervasive Problems in Federal Drug Discounting Program

The 340B drug pricing program was created by Congress in 1992 to make prescription medicines more available to low-income and indigent patient populations. The program has been, and likely will continue to be, fertile ground...more

2/17/2014 - 340B HHS HRSA OIG Pharmaceutical Prescription Drugs

Manufacturers Face Potential Roadblock to Early Challenges to Biologic Drug Patents

Biologic drugs have become increasingly popular in recent years, and now serve as standard treatment options for diseases such as diabetes, anemia, cancer, hepatitis, and multiple sclerosis. Biologics are a class of drugs or...more

11/22/2013 - Biologics Drug Manufacturers FDA Patents Pharmaceutical

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more

11/18/2013 - ANDA Failure To Warn FDA Generic Drugs Labeling Mensing Pharmaceutical Wyeth

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